STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE)
FDA 510(k) clearance K040300 · decided 2004-03-03
Clearance details
- K-number
- K040300
- Device name
- STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE)
- Applicant
- Stryker Instruments
- Decision
- Substantially Equivalent
- Date received
- 2004-02-09
- Decision date
- 2004-03-03
- Days to decision
- 23 days
- Clearance type
- Traditional
- Product code
- ERL
- Device class
- 2
- Regulation number
- 874.4250
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Kalamazoo, MI, US
- Third-party review
- No
- Expedited review
- No
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